MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF; HIP DOUBLE MOBILITY HC LINER

Model Number	01.26.2852MHC
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24-may-2022.Lot 2111789: (b)(4) items manufactured and released on 26-oct-2021.Expiration date: 2026-oct-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Other devices involved: batch review performed on 24-may-2022: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 2107470: (b)(4) items manufactured and released on 29-sep-2021.Expiration date: 2026-sep-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Liner: versafitcup dm 01.26.2854mhc double mobility hc liner 28/dmg (k092265) lot 2114155: (b)(4) items manufactured and released on 15-nov-2021.Expiration date: 2026-oct-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 2113557: (b)(4) items manufactured and released on 10-dec-2021.Expiration date: 2026-nov-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
On (b)(6) 2022, patient had a primary left hip surgery and on (b)(6) 2022 he had a primary right hip surgery.On (b)(6) 2022 the patient came in reporting pain and instability due to signs of infection.The surgeon performed a bilateral revision surgery and revised heads and liners.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF
• Common Device Name: HIP DOUBLE MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14652253
• Report Number: 3005180920-2022-00444
• Device Sequence Number: 17321453
• Product Code: MEH
• UDI-Device Identifier: 07630030807343
• UDI-Public: 07630030807343
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01.26.2852MHC
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 2111789
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male